Archives

• Revenue in Q2 2013 increased by 120% to EUR 343 thousand compared to Q2 2012
• Operating costs decreased by 44% to EUR 2,098 thousand over Q2 2012
• EBIT in Q2 improved by 53% to EUR -1,607 thousand compared to Q2 2012
• Net cash flow in H1 2013 positive due to successful capital increase in January
• Level 1 ADR program established

‘In the first half of 2013, we were pleased to see growing sales of our blood-based colorectal cancer (CRC) test, Epi proColon^(R) in the European and Asian markets, demonstrating growing acceptance of this product. At the same time, we have continued to focus on the approval process at the U.S. Food and Drug Administration (FDA). A series of facility inspections by the FDA have been conducted and we are currently in a constructive dialogue with the agency, awaiting additional feedback on the review process and news regarding the expected advisory board panel meeting date in the near future. We remain confident and anticipate the approval decision regarding our lead product within the second half of this year’, said Dr. Thomas Taapken, CEO/CFO of Epigenomics AG.

H1 2013 Financial Results

• Revenue in H1 2013 significantly increased by 75% to EUR 698 thousand (H1 2012: EUR 399 thousand) driven by strong product sales of EUR 327 thousand and R&D service fees of EUR 246 thousand (Q2 2013: EUR 343 thousand; Q2 2012: EUR 156 thousand; +120%).
• Operating costs decreased by 37% in H1 2013 compared to H1 2012 to EUR 4.3 million (H1 2012: EUR 6.8 million; Q2 2013: EUR 2.1 million; Q2 2012: EUR 3.8 million; -45%). This was primarily attributable to the completed clinical trial (i.e. FIT study) in 2012, which had significantly impacted the 2012 numbers. In addition, it mirrors the Company’s reduction in headcount from 44 employees at the end of H1 2012 to 32 at the reporting date.
• As a consequence of cost reductions, EBIT for H1 2013 improved by 42% to EUR -3.3 million (H1 2012: EUR -5.7 million) and net loss by 42% to EUR 3.3 million (H1 2012: EUR 5.7 million).
• Loss per share in H1 2013 amounted to EUR 0.29 compared to EUR 0.65 in H1 2012 (Q2 2013: EUR 0.14; Q2 2012: EUR 0.38).
• Net cash flow in H1 2013 was positive at EUR 0.8 million (H1 2012: EUR -5.0 million). A major impact on liquidity resulted from the successful capital raise in Q1 2013, through which Epigenomics recorded a net cash inflow of EUR 4.6 million.
• Cash outflow from operating activities was reduced to EUR 3.8 million (H1 2012: EUR 4.8 million). This outflow included payments in connection with the FIT comparison study completed in 2012 and payments for consulting and regulatory services during the ongoing FDA approval process.
• Liquid assets at the end of the period amounted to EUR 3.6 million (December 31, 2012: EUR 2.7 million).

Operational highlights

• FDA Approval Process Progresses as Planned: In the second quarter of 2013, Epigenomics continued to focus on the U.S. approval of its blood-based CRC test, Epi proColon^(R), and proceeded on the regulatory path according to plan. A series of facility inspections by the FDA have been conducted and open topics have been addressed. The Company now awaits feedback from the agency on the review process and an advisory board panel review meeting is expected to be called in by the FDA. Epigenomics remains confident and anticipates the approval decision within the second half of this year. The Company will continue to update the public on all major developments.
• Data of FIT Comparison Study Presented at DDW Conference: In May 2013, results of the head-to-head comparative study between Epi proColon^(R) and fecal immunochemical testing (FIT) were presented at a workshop of the World Endoscopy Organization (WEO) during the Digestive Disease Week (DDW) Conference in Orlando, Florida, U.S.A.
• Product Sales Increasing: Sales of Epigenomics’ products have further gained ground, demonstrating the growing acceptance of the Company’s products in the market. Sales through some of the Epigenomics’ largest established laboratory customers have strengthened and especially the recent collaboration with the Chinese partner BioChain got off to a good start.
• Level 1 ADR Program Established: In July 2013, after the reporting period, Epigenomics announced the establishment of a Level 1 American Depositary Receipt (ADR) program. Epigenomics’ ADRs can now be traded on the OTC (over-the-counter) market under the ticker symbol EPGNY.
• Analysts Coverage Broadened: Research analysts from Kempen & Co., Nomura Code Securities and First Berlin Equity Research have initiated coverage of Epigenomics with ‘buy’ recommendations and valuations ranging between EUR 2.80 and EUR 4.30 per share.
• Changes to the Executive Board: In April 2013, Epigenomics announced the appointment of Dr. Uwe Staub to the Executive Board of the Company as Chief Operating Officer (COO), a position he has held already since September 2012 in a non-executive function.

Outlook

• Based on the half-year results, Epigenomics is now confident to see an increase of revenue for 2013 compared to the previous year. The successful reduction of costs will enable the Company to reach its forecasted financial targets for 2013. In line with previous guidance, EBIT and net loss are expected to be in a range between EUR -6.5 million and EUR -7.5 million respectively for the full year. The expected net loss per share for 2013 will likely be in the range of EUR -0.54 to EUR -0.64, a significant reduction compared to 2012 (EUR -1.38). Cash consumption for 2013 is expected to be approximately EUR 7 million (2012: EUR 10.9 million).
• The most significant milestone for Epigenomics remains the expected U.S. approval for Epi proColon^(R) by the FDA in the second half of 2013. This approval will heavily affect the future value of the Company and its ability to improve its financial situation going forward.
• Current financial resources are expected to fund the Company’s operations into early 2014. Since it is not anticipated that the Company will be able to generate sufficient cash flows from licensing income or product sales in the short-term, Epigenomics is intensively evaluating all financing options available, including the possibility of a further capital increase, in order to secure its business operations beyond this term.

Further Information

Conference call for press and analysts

The full 6-Months Financial Report 2013 can be obtained from Epigenomics’ website at:
https://www.epigenomics.com/en/news-investors/investors/financial-reports/2013.html

Epigenomics’ management will host a conference call with web presentation at 3pm CET/9am ET today, Wednesday, August 7^th, 2013. The conference call will be held in English.

The dial-in numbers for the conference call are:

Dial-in number (within Germany): + 49 69 247 501 895Dial-in number (within the UK): +44 203 367 9216

Dial-in number (within the U.S.): +1 408 916 9838

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

The presentation accompanying the conference call and dial-in details for the web presentation will be available on Epigenomics’ website: https://www.epigenomics.com/en/news-investors.html

Both an audio replay of the conference call and a transcript of the conference call will be provided on Epigenomics’ website subsequently: https://www.epigenomics.com/en/news-investors.html

– Ends –

Contact Epigenomics AG

Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

For US press inquiries:

Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr@epigenomics.com

About Epigenomics

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^(R), 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 and testing laboratories. 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.

Press release

Epigenomics: US study suggests blood-based Septin9 CRC screening could save lives and be health-economically beneficial

– CRC screening with blood-based Septin9 tests has potential to improve screening uptake and adherence rates

– Septin9 testing could decrease colorectal cancer (CRC) incidence by 41% and CRC mortality by 61% at optimal screening uptake rates

– Septin9 based screening shown to be cost-effective over no screening

Berlin, Germany, and U.S.A., July 22, 2013 – Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today announced findings from a health economic study by Prof. Uri Ladabaum, M.D., M.S., et al. from the Division of Gastroenterology and Hepatology, Stanford University School of Medicine, USA.

According to the study, Septin9 testing provides potential for saving lives while being health economically beneficial as an attractive screening alternative to established methods for a population that would otherwise be non-compliant to colorectal cancer screening.

The study, which was published in ‘Cancer Epidemiology, Biomarkers & Prevention’, concluded that Septin9 tests would decrease CRC incidence by 41% and CRC mortality by 61% assuming optimal uptake. In addition, Septin9 tests have the potential to demonstrate significant economic benefits at acceptable costs by increasing screening rates and improving adherence over time compared to other strategies. At 75% adherence with the blood-based Septin9 test, compared to under 20% with stool-based tests (FIT) per screening cycle, Septin9 based CRC screening would be cost-effective. In the comparison, current FIT tests would be more effective and less costly than all other alternatives, assuming optimal uptake, adherence and follow-up, but this has not yet been achieved in practice.

‘Colorectal cancer is the third most common cancer globally and the second most common cancer in industrialized countries. As observed in other cancer indications, screening and early detection of cancers could decrease mortality significantly. Although established screening strategies are very effective and cost efficient, compliance rates are devastatingly low due to the partly invasive and/or uncomfortable nature of the established screening methods. At least one of three eligible US citizens does not undergo CRC screening, resulting in more than 60% of CRC cases being detected in late, symptomatic stages,’ explained Dr. Thomas Taapken, CEO/CFO of Epigenomics AG. ‘CRC screening with a convenient blood test has the potential to significantly improve screening uptake and adherence and ultimately reduce CRC incidence and mortality, as well as resulting healthcare cost.’

The basis for comparison between different screening methods in the Ladabaum study were the published results of the PRESEPT study, run with a prototype version of the Septin9 assay, and historical FIT data. There were no direct comparison data between the two methods at the time. Epigenomics recently conducted a head-to-head comparison study between its Epi proColon(R) test, currently under PMA review by the FDA, and FIT demonstrating non-inferiority of Epi proColon(R) to FIT with respect to sensitivity. The achieved sensitivity for Epi proColon was 73%, compared to 68% for FIT.

– Ends –

Contact Epigenomics AG

Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel. +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

For US press inquiries:

Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr@epigenomics.com

About Epigenomics

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^(R), 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 and testing laboratories. 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.

Epigenomics Establishes American Depositary Receipt (ADR) Program

• Epigenomics ADRs can be traded on US over-the-counter (OTC) market effective as of July 9, 2013
• ADR ticker symbol EPGNY
• 1 ADR represents 5 ordinary company shares

Berlin, Germany, and U.S.A., July 9, 2013 – Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today announced that the Company has established a Level 1 ADR program in the U.S.A. BNY Mellon has been appointed as the depositary bank for the ADR program. ADRs of Epigenomics are US dollar negotiable certificates representing ordinary shares of the Company at a ratio of five ordinary shares to one Epigenomics ADR. Epigenomics ADRs can be traded on the US OTC market effective as of July 9, 2013 under the ticker symbol EPGNY. Ordinary Epigenomics shares are traded in Frankfurt Prime Standard, Germany, under the ticker symbol ECX.

‘In the light of our focused US strategy and the upcoming decision about the approval of our blood-based test for the early detection of colorectal cancer, Epi proColon(R), we experience growing interest of US investors,’ explained Dr. Thomas Taapken, CEO/CFO of Epigenomics AG. ‘We established the ADR program as a service to offer those investors an easy way to buy our shares and to consequently broaden the shareholder base in our core market.’

– Ends –

Contact Epigenomics AG

Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Präsidentenstrasse 1
10178 Berlin
Tel. +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

For US press inquiries:

Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr@epigenomics.com

About Level 1 American Depositary Receipt (ADR) Program

The Level 1 ADR program allows US investors to trade shares in the form of securities from companies that are not listed in the US. ADRs represent ordinary shares of a company at a certain ratio. They are traded on the US over-the-counter (OTC) market and are issued according to the demand (Unsponsored) or in cooperation with one designated depositary bank that acts as the transfer agent (Sponsored). The price generally tracks the price of the foreign security in its home market, adjusted for the ratio of ADRs to foreign company shares.

About Epigenomics

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^(R), 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 and testing laboratories. 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.

Berlin, Germany, and U.S.A., May 15, 2013 – Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today announced that results of the head-to-head comparative study between its blood-based colorectal cancer (CRC) detection test Epi proColon^(R) and fecal immunochemical testing (FIT) will be presented at a workshop of the WEO (World Endoscopy Organization) Colorectal Cancer Screening Committee during this year’s DDW (Digestive Disease Week) Conference in Orlando, FL, U.S.A., on May 17, 2013.

– Epi proColon^(R) demonstrates 74% sensitivity in CRC detection and is non-inferior to FIT

– Blood-based test has potential to increase patient acceptance in CRC screening according to Prof. David Johnson

The results will be presented by Nicholas Potter, Ph.D., Molecular Pathology Laboratory Network, Inc. Maryville, TN, U.S.A., on behalf of the authors, including lead author David A. Johnson, Gastroenterology Division, Eastern VA Medical School, Norfolk, VA, U.S.A., one of the leading gastroenterologists in the US and co-author of several CRC screening guidelines including those of the US Multisociety Task Force and the American College of Gastroenterology.

In the final analysis of the study results, it was demonstrated that Epi proColon^(R) was able to detect 74% of all evaluable CRC cases in this large multi-centric clinical study, in comparison to 67% of CRC cases detected by FIT. Nicholas Potter concluded that it was demonstrated that sensitivity of the plasma-based methylated Septin9 test is statistically non-inferior to a widely recommended stool-based screening test (FIT).

Analysis of Septin9 DNA methylation in plasma represents a straightforward, minimally invasive method to detect all stages of CRC which either alone or in combination with other screening strategies has the potential to satisfy unmet needs for increased compliance in the screening population. Prof. Johnson commented: ‘This technology introduces a new opportunity to increase patient acceptance and compliance with CRC screening. Anything that increases screening should be viewed as a favorable advance in the goal to decrease CRC mortality.’

Dr. Uwe Staub, Chief Operating Officer of Epigenomics, commented: ‘We are very pleased with the final study results, which have now been under review by the FDA since earlier this year. Participation in CRC screening programs and acceptance of recommended methods, including non-invasive stool-based tests, are still too low. Based on the achieved non-inferiority in CRC detection, we believe that Epi proColon^(R) has the potential to significantly drive awareness and acceptance for CRC screening among those who would otherwise be non-compliant.’

WEO Colorectal Cancer Screening Committee Meeting, DDW Workshop 2013:

The presentation titled ‘Use of FIT versus Septin 9: Trial results’ presented by Nicholas T. Potter will be held at the WEO (World Endoscopy Organization) Colorectal Cancer Screening Committee Meeting, DDW 2013 Workshop, in Orlando, FL, U.S.A. on Friday, May 17, 2013 during the session ‘Updates on Screening Methods/ New Tests’ which is scheduled for 3.30 pm to 5.10 pm.

– Ends –

Contact Epigenomics AG

Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Präsidentenstrasse 1
10178 Berlin
Tel. +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

For US press inquiries:

Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr@epigenomics.com

About Epigenomics

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^(R), 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 and testing laboratories. 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.

Epigenomics AG Announces Q1 2013 Financial Results and Reports on Operational Highlights

Berlin, Germany, and, U.S.A., May 8, 2013 – Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today announced its financial results for the first quarter ending March 31, 2013.

• U.S. Food and Drug Administration (FDA) accepted Premarket Approval (PMA) submission for Epi proColon^(R) and granted priority review status
• Revenue Q1 2013 increased 46% compared to Q1 2012
• New distribution agreement for China signed
• R&D costs decreased 27% compared to Q1 2012
• EBIT in Q1 improved by 26% compared to Q1 2012
• Net cash flow in Q1 2013 positive due to successful capital increase in January

‘During the first quarter of 2013, we continued to make progress on the regulatory path towards U.S. approval of Epi proColon^(R). After completion of our PMA submission late last year, the FDA notified us of having accepted the application for review and has granted priority review status to it. We are very positive about this decision and continue our constructive discussion with the agency. Several inspections have already been conducted and we are excited with the progress made so far’, said Dr. Thomas Taapken, CEO/CFO of Epigenomics AG. ‘The successful capital raise earlier this year provides us with the funds to keep working on bringing the advantages of Epi proColon^(R), a convenient blood-based testing for early detection of colorectal cancer, to the screening eligible population.’

Q1 2013 Financial Results

– Q1 2013 revenues increased by 46% to EUR 355 thousand (Q1 2012: EUR 243 thousand) due to an increase in product sales (+31%) and R&D service fees.

– R&D costs decreased by 27% to EUR 1.1 million (Q1 2012: EUR 1.4 million). This was primarily attributable to the comparison study, which was terminated at the end of 2012 and significantly had affected the 2012 numbers as well as to the now fully visible effects of the company restructuring in late 2011, resulting in a reduction in headcount from 46 employees at the end of Q1 2012 to 33 at the reporting date.

– As a result of the headcount reduction SG&A costs also declined significantly by 27% to EUR 1.0 million (Q1 2012: EUR 1.4 million).

– EBIT for Q1 2013 amounted to EUR -1.7 million (Q1 2012: EUR -2.3 million) and net loss to EUR 1.7 million (Q1 2012: EUR 2.3 million) – an improvement of about 26% each.

– Net cash flow in Q1 2013 was positive at EUR 2.8 million (Q1 2012: EUR -2.6 million).
A major impact on liquidity resulted from the successful capital raise, through which Epigenomics recorded a net cash inflow of EUR 4.6 million. Cash outflow from operating activities was reduced to EUR 1.8 million (Q1 2012: EUR 2.5 million).

– Liquid assets at the end of the period amounted to EUR 5.5 million (December 31, 2012: EUR 2.7 million).

Operational highlights

– FDA Approval Process Progresses as Planned: During the first quarter of 2013, the U.S. Food and Drug Administration (FDA) notified the Company of having accepted the application for U.S. approval of Epi proColon^(R) for review and has granted it priority review status. Several inspections have already been conducted so far and the progress made is encouraging. An advisory board panel review meeting is expected to be called by the FDA as part of the review process. The Company will continue to update the public on all major developments.

– In parallel, Epigenomics continues to make all necessary efforts in the U.S. to create awareness for the test and generate support in the medical and laboratory customer communities to achieve inclusion of the test in screening guidelines and assure the availability of reimbursement by insurance carriers once the product is approved.

– Product Sales Increasing: Sales of Epigenomics’ products are increasing gradually. While this demonstrates the growing acceptance for the Company’s products in the market, it also is a result of our maturing basis of customers and distributors.

– Agreement with BioChain for China: In March 2013, BioChain – a leading laboratory services provider in Asian markets – has licensed Epigenomics’ methylated Septin9 marker to make a blood-based assay for the convenient detection of colorectal cancer (CRC) available in China, where prevalence of CRC is on the rise and growing awareness is creating a need for early detection.

– Successful Capital Increase: In January 2013, Epigenomics successfully completed a capital increase by way of a rights issue and a subsequent private placement, which extended the cash runway of the Company at least until the end of 2013. A total number of 3,149,430 new shares were issued at a price of EUR 1.58, resulting in gross proceeds of EUR 5.0 million.

– Changes to the Executive Management: Early April 2013, Epigenomics announced the appointment of Dr. Uwe Staub to the Executive Board of the Company as Chief Operating Officer (COO), a position he has held since September of 2012 in a non-executive function. He joined the Executive Board as a second member in addition to Dr. Thomas Taapken, acting CEO and CFO of Epigenomics AG.

Outlook

– The Company confirms its financial prognosis for the current business year as published in its Group management report for 2012. Prior to the approval of Epi proColon^(R) as an IVD product in the U.S. market, Epigenomics remains cautious and does not expect revenue to increase significantly compared to 2012 levels. EBIT and net loss for 2013 are expected to be significantly lower than in 2012 as the effects of the 2011 restructuring measures now become fully visible as well as due to significantly reduced R&D expenses. Net loss and cash consumption for 2013 are both expected to be in the range of EUR 6.5 to 7.5 million.

– The most significant milestone for Epigenomics will be the expected U.S. approval for Epi proColon^(R) by the FDA in the second half of 2013, in order to start the commercialization of the product in the most relevant market of the world. This approval will heavily affect the future value of the Company and its financial situation.

– Current financial resources are expected to fund the Company’s operations at least until the end of 2013. Since it is not anticipated that the Company will be able to generate sufficient cash flows from licensing income or from product sales in the short-term, Epigenomics will continue to evaluate all strategic options available, including the possibility of a further capital increase, in order to secure its business operations beyond this term.

Further Information

The full Q1 Financial Report 2013 can be obtained from Epigenomics’ website at: https://www.epigenomics.com/en/news-investors/investors/financial-reports/2013.html

– Ends –

Contact Epigenomics AG

Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Präsidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

For US press inquiries:

Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr@epigenomics.com

About Epigenomics

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^(R), 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 and testing laboratories. 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.