Not for distribution in the United States
Berlin, Germany, and Seattle, WA, U.S.A., December 20, 2012 – Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today announced the intention to launch a capital increase by way of a rights issue in January 2013. With the capital increase the Company plans to generate gross proceeds of up to just under EUR 5 million and aims to extend the cash runway of the Company at least into Q4 2013.
In line with previous announcements, and supported by the recently published results of a comparison study of the company’s lead CRC screening product Epi proColon® to fecal immunochemical testing (FIT), Epigenomics will continue to explore all strategic options for the Company in its further development, especially including the option of securing additional financial resources to support the Company’s operations up to and beyond a potential U.S. Food and Drug Administration (FDA) approval for Epi proColon® in 2013.
Dr. Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer of Epigenomics, commented: “We are very thankful to our shareholders who supported the development of the Company and its lead product Epi proColon® over the last years. The recently announced results of the comparison study to FIT are a major milestone for Epigenomics that enable us to move ahead with our Premarket Approval (PMA) filing with FDA as planned before the end of 2012. The contemplated transaction is in our view in the best interest the Company and its shareholders at this time, as it brings the Company closer to potential FDA approval for Epi proColon®, while alleviating the current financial situation of the Company.”
Epigenomics Executive Board, with the approval of the Supervisory Board, has taken the decision to implement an increase of the issued share capital by utilization of authorized capital. The capital increase shall be carried out by way of a rights issue against cash contributions. It shall be structured in such a manner that the gross proceeds generated under the capital increase will amount to up to just under EUR 5,000,000 in order to make use of the available exemption from the publication of a prospectus under German securities laws.
The Supervisory and Executive boards of the Company plan to resolve the details of the capital increase in early January 2013, in particular the maximum number of new shares and the subscription ratio, which will then be published by way of an ad hoc announcement without undue delay. Publication of the subscription offer and beginning and end of the subscription period will subsequently take place in line with German market practice.
The new shares will first be offered to the shareholders of the Company. Shares not taken up by shareholders might subsequently be offered in a private placement to institutional investors.
Epigenomics AG intends to use the net proceeds from the offering to finance its current operations and to build and strengthen the distribution capacities for its products.
Recent events and outlook
The Company recently announced results of the head-to-head comparison study between its blood-based Epi proColon® and FIT for the detection of colorectal cancer and remains to be on track to file the final module of the PMA submission with the FDA before the end of this year. A subsequent decision by the FDA on the PMA submission for Epi proColon® is expected during the second half of 2013.
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Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.
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.
The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.