Epigenomics AG / Key word(s): Study/Miscellaneous
24.04.2014 12:10
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.), Beijing (China),
April 24, 2014 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX:
EPGNY), and BioChain Institute Inc. (BioChain), today announced that
BioChain has completed its major clinical validation study to validate
Epigenomics' blood-based Septin9 screening assay Epi proColon(R) for the
early detection of colorectal cancer (CRC) with the goal to gain market
approval for the test in China. In addition, BioChain has officially
submitted an application to the China Food and Drug Administration (CFDA)
in April for the approval of Epi proColon(R). Both companies expect
commercialization of the test in China to start in 2015.
The clinical validation study was designed to evaluate the clinical
performance of Epi proColon(R) for the detection of CRC and is part of the
required data package to seek regulatory approval in China. From November
2013 to March 2014, a total of 1,074 patients at three top ranking
hospitals in China were tested by using Epigenomics' Epi proColon(R) 2.0 CE
assay. Epi proColon(R) detected 74.8% of the cancer cases (sensitivity) and
correctly identified 97.4% of the patients free of disease (specificity).
The tested study cohort included 300 cancer cases in stages I to IV. The
results were marked as positive when at least two out of three samples of
the test triplicate were evaluated as positive.
The results were in line with those achieved in Epigenomics' European CE
marking study reported in 2011, which followed the same principle of data
interpretation (80% sensitivity and 99% specificity).
- End of Ad hoc -
Contact Epigenomics AG
Antje Zeise CIRO
Manager IR | PR
Epigenomics AG
Phone: +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com
Epigenomics' legal disclaimers. 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.
24.04.2014 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: Epigenomics AG
Kleine Präsidentenstraße 1
10178 Berlin
Germany
Phone: +49 30 24345-0
Fax: +49 30 24345-555
E-mail: ir@epigenomics.com
Internet: www.epigenomics.com
ISIN: DE000A1K0516
WKN: A1K051
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart
End of Announcement DGAP News-Service
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Archives
24. April 2014
Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): Epigenomics’ Partner BioChain Successfully Completes Clinical Validation Study for CFDA Approval of Epi proColon(R) in China
04. April 2014
DGAP-DD: Epigenomics AG deutsch
Mitteilung über Geschäfte von Führungspersonen nach §15a WpHG
Directors’-Dealings-Mitteilung übermittelt durch die DGAP.
Für den Inhalt der Mitteilung ist der Mitteilungspflichtige verantwortlich.
—————————————————————————
Angaben zum Mitteilungspflichtigen
Name: Kessler
Vorname: Ann Clare
Firma: Epigenomics AG
Funktion: Verwaltungs- oder Aufsichtsorgan
Angaben zum mitteilungspflichtigen Geschäft
Bezeichnung des Finanzinstruments: Aktie
ISIN/WKN des Finanzinstruments: DE000A1K0516
Geschäftsart: Kauf
Datum: 31.03.2014
Kurs/Preis: 7,4587
Währung: USD
Stückzahl: 5000
Gesamtvolumen: 37293,50
Ort: Over the Counter Market
Angaben zum veröffentlichungspflichtigen Unternehmen
Emittent: Epigenomics AG
Kleine Präsidentenstraße 1
10178 Berlin
Deutschland
ISIN: DE000A1K0516
WKN: A1K051
Ende der Directors’ Dealings-Mitteilung
(c) DGAP 04.04.2014
Die DGAP Distributionsservices umfassen gesetzliche Meldepflichten,
Corporate News/Finanznachrichten und Pressemitteilungen.
DGAP-Medienarchive unter www.dgap-medientreff.de und www.dgap.de
ID 18631
31. March 2014
Epigenomics AG: Veröffentlichung der Gesamtzahl der Stimmrechte nach § 26a WpHG mit dem Ziel der europaweiten Verbreitung
Epigenomics AG / Veröffentlichung der Gesamtzahl der Stimmrechte
31.03.2014 13:49
Veröffentlichung der Gesamtzahl der Stimmrechte nach § 26a WpHG, übermittelt durch die DGAP - ein Unternehmen der EQS Group AG.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
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Hiermit teilt die Epigenomics AG mit, dass die Gesamtzahl der Stimmrechte
am Ende des Monats März 2014 insgesamt 13510892 Stimmrechte beträgt.
31.03.2014 Die DGAP Distributionsservices umfassen gesetzliche
Meldepflichten, Corporate News/Finanznachrichten und Pressemitteilungen.
DGAP-Medienarchive unter www.dgap-medientreff.de und www.dgap.de
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Sprache: Deutsch
Unternehmen: Epigenomics AG
Kleine Präsidentenstraße 1
10178 Berlin
Deutschland
Internet: www.epigenomics.com
Ende der Mitteilung DGAP News-Service
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31. March 2014
DGAP-DD: Epigenomics AG deutsch
Mitteilung über Geschäfte von Führungspersonen nach §15a WpHG
Directors’-Dealings-Mitteilung übermittelt durch die DGAP.
Für den Inhalt der Mitteilung ist der Mitteilungspflichtige verantwortlich.
—————————————————————————
Angaben zum Mitteilungspflichtigen
Name: Staub
Vorname: Uwe
Firma: Epigenomics AG
Funktion: Geschäftsführendes Organ
Angaben zum mitteilungspflichtigen Geschäft
Bezeichnung des Finanzinstruments: Aktie
ISIN/WKN des Finanzinstruments: DE000A1K0516
Geschäftsart: Kauf
Datum: 31.03.2014
Kurs/Preis: 5,29
Währung: EUR
Stückzahl: 5000
Gesamtvolumen: 26450,00
Ort: XETRA
Angaben zum veröffentlichungspflichtigen Unternehmen
Emittent: Epigenomics AG
Kleine Präsidentenstraße 1
10178 Berlin
Deutschland
ISIN: DE000A1K0516
WKN: A1K051
Ende der Directors’ Dealings-Mitteilung
(c) DGAP 31.03.2014
Die DGAP Distributionsservices umfassen gesetzliche Meldepflichten,
Corporate News/Finanznachrichten und Pressemitteilungen.
DGAP-Medienarchive unter www.dgap-medientreff.de und www.dgap.de
ID 18604
28. March 2014
Epigenomics AG: Epigenomics AG Publishes 2013 Annual Report and Provides Outlook for the Year 2014
|
Epigenomics AG / Key word(s): Final Results 28.03.2014 / 08:30
Berlin (Germany) and Germantown, MD (U.S.A.), March 28, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, announced that it has published today the annual report for the fiscal year ending December 31, 2013 and an outlook for the year 2014. The Company already published 2013 preliminary financial results and operational highlights on February 26, 2014. Epigenomics confirmed that revenue in 2013 increased by 53% to approximately EUR 1.6 million (2012: EUR 1.0 million), operating loss (EBIT) was significantly reduced by 40% to EUR 7.3 million (2012: EUR 12.1 million) and net loss was reduced by 39% to EUR 7.4 million (2012: EUR 12.2 million) which equals a loss per share of EUR 0.62 (2012: EUR 1.38). Cash consumption in 2013 amounted to EUR 6.5 million (2012: EUR 10.9 million) and year-end liquidity including marketable securities to EUR 8.0 million (2012: EUR 2.7 million). “2013 was a good year for Epigenomics. We were able to successfully establish important strategic partnerships to support the commercialization of our key product Epi proColon(R) following potential regulatory approval in the U.S. and to develop new markets, for example China. In addition, we significantly improved our financial position and increased our financial flexibility by raising EUR 12.5 million, in a series of transactions,” said Dr. Thomas Taapken, CEO/CFO of Epigenomics. “We are pleased with the advice of the FDA’s Medical Devices Advisory Committee for our blood-based colorectal cancer screening test that we announced yesterday. This recommendation is a big milestone for the Company and we will discuss results of the meeting in more detail during today’s conference. We will now define an approval path with the FDA to launch Epi proColon(R) in the U.S. as soon as possible and believe we are best positioned to bring sustainable value to our shareholders through prosperous product launches in major markets.” Outlook for 2014 The complete annual report 2013 including an outlook for 2014 can be downloaded from the Company’s website under https://www.epigenomics.com/en/news-investors/investors/financial-reports/2013.html. Epigenomics AG will host a conference for journalists, analysts and investors today, March 28, 2014 from 1:00 pm to 2:30 pm CET at equinet Bank AG, Gräfstrasse 97, Frankfurt am Main in German language followed by a conference call starting at 3:00 pm CET in English language. Management will discuss the detailed results for the financial year 2013 and provide an update on the FDA Advisory Committee meeting. The conference call will be webcasted and can be accessed on Epigenomics’ website under www.epigenomics.com. -Ends- Contact Epigenomics AG For US press inquiries: About Epigenomics Epigenomics’ legal disclaimers. 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.
End of Corporate News 28.03.2014 Dissemination of a Corporate News, transmitted by DGAP – a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. DGAP’s Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| Language: | English | |
| Company: | Epigenomics AG | |
| Kleine Präsidentenstraße 1 | ||
| 10178 Berlin | ||
| Germany | ||
| Phone: | +49 30 24345-0 | |
| Fax: | +49 30 24345-555 | |
| E-mail: | ir@epigenomics.com | |
| Internet: | www.epigenomics.com | |
| ISIN: | DE000A1K0516 | |
| WKN: | A1K051 | |
| Listed: | Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart | |
| End of News | DGAP News-Service |
|
|
| 260215 28.03.2014 |
28. March 2014
DGAP-DD: Epigenomics AG deutsch
Mitteilung über Geschäfte von Führungspersonen nach §15a WpHG
Directors’-Dealings-Mitteilung übermittelt durch die DGAP.
Für den Inhalt der Mitteilung ist der Mitteilungspflichtige verantwortlich.
—————————————————————————
Angaben zum Mitteilungspflichtigen
Name: Dr. Taapken
Vorname: Thomas
Funktion: Geschäftsführendes Organ
Angaben zum mitteilungspflichtigen Geschäft
Bezeichnung des Finanzinstruments: Aktie
ISIN/WKN des Finanzinstruments: DE000A1K0516
Geschäftsart: Kauf
Datum: 28.03.2014
Kurs/Preis: 5,336
Währung: EUR
Stückzahl: 5000
Gesamtvolumen: 26680,00
Ort: XETRA
Zu veröffentlichende Erläuterung:
Preisspanne EUR 5,35 bis EUR 5,29 je Aktie; Mittelwert (gewichtet und
gerundet): EUR 5,336
Angaben zum veröffentlichungspflichtigen Unternehmen
Emittent: Epigenomics AG
Kleine Präsidentenstraße 1
10178 Berlin
Deutschland
ISIN: DE000A1K0516
WKN: A1K051
Ende der Directors’ Dealings-Mitteilung
(c) DGAP 28.03.2014
Die DGAP Distributionsservices umfassen gesetzliche Meldepflichten,
Corporate News/Finanznachrichten und Pressemitteilungen.
DGAP-Medienarchive unter www.dgap-medientreff.de und www.dgap.de
ID 18588