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Epigenomics AG successfully completes capital increase

Berlin, March 31, 2020 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) has fully placed the new shares from the capital increase resolved on March 30, 2020 of up to EUR 3,602,154.00 at a price of EUR 1.11 per new share. Accordingly, the Company’s share capital will be increased from currently EUR 43,527,692.00 by EUR 3,602,154.00 to EUR 47,129,846.00 by issuing up to 3,602,154 new registered no par value shares of the Company against cash contributions.

The new shares were fully subscribed by institutional investors from Germany and the U.S.A. by way of a private placement with the exclusion of the shareholders’ subscription rights and carry full dividend rights as of January 1, 2019.

The gross proceeds from the capital increase amount to approximately EUR 4.0 million.

Subject to the registration of the entry of the capital increase in the commercial register and any delays caused by the COVID 19 pandemic, the Company assumes that the admission of the new shares to the regulated market (Prime Standard) of the Frankfurt Stock Exchange will probably take place on or around April 3, 2020.

Epigenomics AG intends to use the net proceeds from the capital increase primarily to finance its ongoing operations.
 

Contact:
Company
Epigenomics AG, Geneststraße 5, 10829 Berlin
Phone +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,
Phone +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.

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 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 FOR PUBLICATION, DISTRIBUTION OR TRANSMISSION TO OR WITHIN THE UNITED STATES OF AMERICA, CANADA, JAPAN AND AUSTRALIA

Epigenomics AG decides to increase share capital by way of private placement

Berlin, March 30, 2020 – The Executive Board of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) today resolved, with approval of the Supervisory Board, to increase the share capital using the Authorized Capital 2019/I. The Company’s share capital shall be increased from currently EUR 43,527,692.00 by up to EUR 3,602,154 to up to EUR 47,129,846.00 by issuing up to 3,602,154 new registered no par value shares of the Company against cash contributions. The placement price per new share will be determined following a bookbuilding process. The new shares will be offered by way of a private placement to institutional investors with the exclusion of the shareholders’ subscription rights and carry full dividend rights as of January 1, 2019.

M.M.Warburg & CO (AG & Co.) Kommanditgesellschaft auf Aktien is acting as sole underwriter of the transaction. The sole placement agent for the private placement in the U.S.A. is Raymond James & Associates, Inc.
 

Contact:
Company
Epigenomics AG, Geneststraße 5, 10829 Berlin
Phone +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,
Phone +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.

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 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.

Epigenomics Announces Postponement of Annual General Meeting due to Coronavirus and Preliminary 2019 Flash Financial Results

Berlin (Germany), March 17, 2020 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), today announced the postponement of their Annual General Meeting (AGM) due to the Coronavirus (COVID-19). The World Health Organization recently declared the coronavirus outbreak a worldwide pandemic. Governments all over the world are implementing various containment measures in an effort to reduce the spread of the disease and minimize fatalities. Specifically, both the German and United States governments are implementing various travel restrictions and/or limitations on public gatherings. In light of the continuing uncertainty surrounding these events and potential future measures enacted by the German government, Epigenomics is postponing its May 14, 2020 Annual General Meeting in the interest of public safety. Due to the statutory lead time required for holding the AGM, the Company must make this decision at this time based on the potential impact and duration of this pandemic.

As the coronavirus continues to spread in Germany and elsewhere, the Company expects the next couple of weeks and potentially months to remain fluid. As such, Epigenomics has also decided to move the release of full year 2019 results from March 27, 2020 to April 29, 2020. This decision is based upon the goal of maximizing the safety of employees, customers, vendors and fellow citizens. Epigenomics’ management notes that the preliminary year-end flash financial results (unaudited) were revenue of EUR 1.1 million, Adjusted EBITDA of EUR -13.3 million and Cash Burn of EUR -13.5 million. All these results are within the guideline ranges provided in the Q3 2019 earnings call. The Company looks forward to providing a full year-end financial update on April 29, 2020.

The worldwide financial markets have experienced tremendous volatility and downward pressure due to the COVID-19 pandemic. Epigenomics’ share price has also been negatively affected despite the recent achievement of a major milestone, the Centers for Medicare and Medicaid Services (CMS) opening the National Coverage Determination (NCD) for Epi proColon. While the pandemic will certainly have negative revenue implications for numerous businesses worldwide, the Company believes that the impact on its 2020 revenue should be negligible and with the now “opened” NCD on February 28, 2020, the proposed coverage determination will be issued by August 28, 2020, and a final decision will be published by November 28, 2020. Issuance of a positive coverage decision would result in only one month of reimbursement in 2020. The executive board assumes that realization of commercial test volume and revenue ramp will occur in 2021.

The management will continue to monitor this unprecedented situation and notify stakeholders accordingly. It is important for Epigenomics to act as a good corporate steward in the interest of public safety. Public health experts advise that the best way to mitigate the spread of COVID-19 at this time is through social distancing in order to minimize the number of interactions that provide opportunities for the disease to spread. Epigenomics does not make these decisions lightly, but believes it is in the best interest of everyone’s safety.
 

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.

Centers for Medicare & Medicaid Services open NCD review process for Epi Pro Colon

• Opening of review process guarantees reimbursement decision within next nine months
• Results of microsimulation model published in November 2019 show competitiveness of Epi proColon compared to other currently recommended colorectal cancer (CRC) screening methods

Berlin (Germany) and San Diego, CA (USA), 02.03.2020 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the U.S. Centers for Medicare & Medicaid Services (CMS) have opened the National Coverage Determination (NCD) review of Epi proColon, Epigenomics’ blood test for colorectal cancer screening. The NCD is one of two options to obtain CMS coverage for Epi proColon, which would represent a major U.S. market breakthrough for the company. The opening of the review process obliges CMS by statute to take a decision on the reimbursement of Epi proColon within a maximum period of nine months.

Greg Hamilton, CEO of Epigenomics AG: “The opening of the NCD review process is a milestone for our company. For nearly four years since FDA approval of Epi proColon, there has been uncertainty as to when and whether CMS will reimburse Epi proColon. Now we know that a reimbursement decision will be made within the next nine months. We hope that the findings of the microsimulation model developed by experts at Harvard Medical School along with the key studies supporting FDA-approval of the product will result in CMS making a positive reimbursement decision.”

The microsimulation model demonstrates that Epi proColon administered annually can reduce the incidence and mortality of colorectal cancer nearly equivalent or better than other approved methods. Additionally, when adherence is included as a variable in the model, the blood test can outperform all other CRC screening strategies in terms of long-term benefits including the reduction in CRC incidence and mortality rates.

With the opening of the NCD, a 30-day period for public comments begins. This comment period is part of a six-month review period during which CMS is required by legal statute to publish a proposed decision. If this proposed coverage decision is positive, another 30-day comment period follows. A final decision on the reimbursement will then be published by CMS within 90 days of the initial proposed decision.
 

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.

Publication of inside information pursuant to Article 17 MAR

Centers for Medicare & Medicaid Services open NCD review process for Epi proColon

Berlin, 28.02.2020– Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the Centers for Medicare & Medicaid Services (CMS) have opened the National Coverage Determination (NCD) review of Epi proColon, Epigenomics’ blood test for colorectal cancer screening. This means that according to the statutes, a decision on CMS’s reimbursement of Epi proColon must be made within a maximum period of nine months. A positive CMS reimbursement decision would represent a major breakthrough for the company in the commercialization of Epi proColon in the U.S. market.
 

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

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 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.