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Epigenomics AG: Epigenomics AG Welcomes Reimbursement for Septin9 Testing by French Insurance Provider

Epigenomics AG / Key word(s): Miscellaneous

12.12.2013 / 08:45


Berlin, Germany, and U.S.A., December 12, 2013 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, today announced that MACSF (Mutuelle d’Assurance du Corps de Santé Français), the leading French supplementary insurance provider for the medical community, will provide the blood-based Septin9 test for the early detection of colorectal cancer (CRC) as part of their additional health insurance program. MACSF will reimburse EUR 50 on what its policy holders pay for undergoing Septin9 testing.

MACSF offers about 800.000 policy holders from the medical community and their families, such as doctors from the private and public sector, other medical or paramedical workers including medical students an additional health insurance, called ‘Mutuelle’. After Swiss Life announced to provide Septin9 as part of its preventive health program in July 2012, MACSF is the second healthcare provider in France and the first ‘Mutuelle’ to reimburse blood-based colorectal cancer screening.

Dr. Thomas Taapken, CEO/CFO of Epigenomics, commented: ‘We are extremely pleased to experience this growing support by French insurance providers. The fact that also MACSF now offers blood-based Septin9 tests to its customers shows the importance of an alternative convenient and non-invasive screening method. And, as their policy holders originate primarily from the medical community, we also hope to raise awareness and convince doctors of our Septin9-based test Epi proColon(R), so that they increasingly recommend it to their patients’.

– Ends –

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 and China. 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.

About MACSF

MACSF Group (Mutuelle d’Assurance du Corps de Santé Français) is for over 75 years the leading insurance provider for healthcare professionals in France. Its mission is to provide supplementary insurance services for private or work-related risks for its members working in the private or public healthcare space.

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

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.

End of Corporate News


12.12.2013 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.
Media archive at www.dgap-medientreff.de and www.dgap.de



244429  12.12.2013
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Epigenomics AG: Epigenomics AG Secures Additional Financing

Epigenomics AG / Key word(s): Corporate Action

04.12.2013 / 09:20


Berlin, Germany, and U.S.A., December 4, 2013 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, today announced that it has obtained a commitment for an additional financing. Through the issuance of convertible bonds, the Company will immediately receive gross proceeds of EUR 2.5 million and upon conversion of the bonds is eligible to receive additional payments of up to EUR 15.7 million. Maxim Group LLC acted as exclusive agent in the placement of these new securities.

Dr. Thomas Taapken, CEO/CFO of Epigenomics, commented: ‘With the issuance of these convertible bonds, we have not only potentially secured the funds necessary to carry our business operations beyond the potential FDA approval of our Epi proColon(R) blood-based colorectal cancer screening test, but also secured access to additional inflows from financing of up to EUR 15.7 million, allowing to satisfy demand from US institutional investors accustomed to invest in convertible bond issues to participate in the future development of Epigenomics. For our current shareholders, this represents also an attractive possibility to benefit from a possible approval of our product in the future.’ He further added: ‘We have significantly improved the financial stability of the Company over the course of 2013 and do look optimistically into an eventful year to come’.

The key terms and conditions are summarized as follows:

  • The newly issued bonds have a total principal amount of EUR 2.675 million and are denominated as 25 bonds of EUR 107.000 each. They are being offered at EUR 2.500 million, representing a 7% issuance discount.
  • Initially, the bonds are being offered with pre-emptive rights to existing shareholders, who can exercise their pre-emptive rights until 24:00 CET on December 18, 2013. Subject to certain conditions, a US institutional investor has committed to purchase any or all bonds which are not subscribed for by existing shareholders.
  • The conversion price will be set at up to EUR 6.86, representing a 10% premium to yesterday’s average trading price of the Company’s common stock and is subject to adjustment during the pre-emptive rights offering period, but can in no case be less than EUR 4.99. The final conversion price will be determined 3 days before the end of the pre-emptive offer period.
  • The bonds are convertible at any time at the option of the holders of the bonds into up to 2.675 million common shares of the Company through an additional payment of up to EUR 15.7 million, but in no case less than 10.7 million at the time of conversion depending on the conversion price.
  • The bonds carry no interest and will mature on December 31, 2015, at which time the bonds will automatically convert into up to 389,941 but in no case more than 536,072 new common shares of the Company, depending on the conversion price.
  • From August 1, 2014, onwards, investors are able to redeem the bonds at their face value upon request.
  • Upon meeting certain conditions, including FDA approval of Epi proColon(R) and meeting certain share price and trading volume thresholds, the Company may force the holders of the bonds to convert their bonds into common shares of the Company at a 40% premium to the conversion price.

The detailed terms and conditions are explained in detail in the pre-emption offer, which has been published on the Company’s website.

– Ends –

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 and China. 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.

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

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.

End of Corporate News


04.12.2013 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.
Media archive at www.dgap-medientreff.de and www.dgap.de



243012  04.12.2013
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Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): Epigenomics AG issues convertible bonds of up to EUR 2.68m

Epigenomics AG  / Key word(s): Corporate Action

04.12.2013 01:09

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.

---------------------------------------------------------------------------

Berlin, Germany, December 3, 2013 - Epigenomics AG (ISIN: DE000A1K0516)
announces that its Executive and Supervisory Boards today have resolved on
the issuance of convertible bonds in the aggregate principal amount of up
to EUR 2,675,000.00, exchangeable in into up to 2,675,000 shares of
Epigenomics' common stock.

The convertible bonds will first be offered to the Company's existing
shareholders for subscription at an issue price of EUR 100,000 per
convertible note with a principal amount of EUR 107,000 each by way of a
rights offering. The Rights Offering is expected to be published on the
Company's website (www.epigenomics.com) and in the German Federal Gazette
('Bundesanzeiger') on December 4, 2013. The subscription period for the
Company's shareholders is expected to begin on December 5, 2013 and to end
on December 18, 2013, including these two days. Epigenomics has entered
into a backstop agreement with an US institutional investor, which agreed
to acquire all convertible notes not subscribed for by Epigenomics'
shareholders during the rights offering at the same conditions as offered
to shareholders.

The convertible notes will bear no interest (zero coupon) and are due for
redemption at their principal amount on December 31, 2015. The Company has
the right to require conversion upon maturity. After August 1, 2014,
bondholders have the right to require redemption of the convertible bonds
at their principal amount.

Subject to dilution adjustments, each convertible note will be convertible
into 107,000 freely tradable shares of Epigenomics' common stock against
payment of a conversion premium that equals the product of (A) the
conversion price minus EUR 1.00 multiplied with (B) the number of shares to
be issued upon conversion (i.e. 107,000). The 'Conversion Price' will be
set on three days prior to the end of the subscription period and shall
equal the XETRA-volume weighted average quotation of Epigenomics' shares
over the last three (3) trading days prior to the time when the conversion
price is determined, but not more than EUR 6.86 (provided that such cap is
not less than 80% of the non-weighted average stock exchange price of the
shares as quoted on XETRA during the Subscription Period until the third
day prior to its end. Epigenomics has certain further rights to require
conversion upon maturity of the convertible bonds or upon FDA approval of
its lead product Epi proColon(R), a blood-based test for the detection of
colorectal cancer.

Epigenomics intends to use the proceeds from the offering and conversion of
the bonds to fund its business operations beyond the FDA approval of its
lead product, Epi proColon(R). Among others, certain preparatory activities
for the marketing of the test are intended to be funded by the proceeds
from the offering.

- 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.


04.12.2013 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

---------------------------------------------------------------------------
 
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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Epigenomics AG: Veröffentlichung der Gesamtzahl der Stimmrechte nach § 26a WpHG mit dem Ziel der europaweiten Verbreitung

Epigenomics AG  / Veröffentlichung der Gesamtzahl der Stimmrechte

29.11.2013 10:45

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.

---------------------------------------------------------------------------

Hiermit teilt die Epigenomics AG mit, dass die Gesamtzahl der Stimmrechte
am Ende des Monats November 2013 insgesamt 13082892 Stimmrechte beträgt.



29.11.2013 Die DGAP Distributionsservices umfassen gesetzliche 
Meldepflichten, Corporate News/Finanznachrichten und Pressemitteilungen. 
DGAP-Medienarchive unter www.dgap-medientreff.de und www.dgap.de

---------------------------------------------------------------------------
 
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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Epigenomics AG: Epigenomics AG Announces FDA Advisory Committee Meeting to Review Epi proColon(R)

Epigenomics AG / Key word(s): Miscellaneous

27.11.2013 / 16:30


Berlin, Germany, and U.S.A., November 27, 2013 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, today announced that the Company was informed by the U.S. Food and Drug Administration (FDA) via the premarket approval (PMA) review process for Epi proColon(R) that the Meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee has been tentatively scheduled for Tuesday, March 25th, 2014. Epigenomics expects the final date for the meeting will be announced publicly via a Federal Register notification. Epi proColon(R) is Epigenomics’ blood-based screening test for colorectal cancer.

The Company had completed filing a PMA submission in early 2013, which was subsequently accepted for review and granted priority review status by the FDA in February 2013.

‘We are extremely pleased to announce that the FDA Advisory Committee meeting for our blood based colorectal cancer screening test has now been scheduled. After having completed all outstanding questions and information requests by the FDA, this represents an important step forward in bringing Epi proColon(R) to physicians and patients in North America’, explained Thomas Taapken, CEO/CFO of Epigenomics. ‘We are looking forward to discussing Epi proColon(R) in front of key opinion leaders in the US, who play an important role in FDA review process.’

– Ends –

About FDA’s advisory committee meetings

The FDA uses 50 committees and panels to obtain independent expert advice on scientific, technical, and policy questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee’s recommendation, but it takes its advice into consideration when reviewing certain submissions. The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics and makes appropriate recommendations to FDA. For more information also refer to:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/default.htm

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 under regulatory review for the U.S.A. The Company’s technology and products have been evaluated 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.

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

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.

End of Corporate News


27.11.2013 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.
Media archive at www.dgap-medientreff.de and www.dgap.de



241997  27.11.2013
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Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): Epigenomics AG Announces FDA Advisory Committee Meeting to Review Epi proColon(R)

Epigenomics AG  / Key word(s): Miscellaneous

27.11.2013 16:30

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.

---------------------------------------------------------------------------

Berlin, Germany, November 27, 2013 - Epigenomics AG (ISIN: DE000A1K0516)
announces that the Company was informed by the U.S. Food and Drug
Administration (FDA) via the premarket approval (PMA) review process for
Epi proColon(R) that the Meeting of the Molecular and Clinical Genetics
Panel of the Medical Devices Advisory Committee has been tentatively
scheduled for Tuesday, March 25th, 2014. Epigenomics expects the final date
for the meeting will be announced publicly via a Federal Register
notification. Epi proColon(R) is Epigenomics' blood-based screening test
for colorectal cancer.

The Company had completed filing a PMA submission in early 2013, which was
subsequently accepted for review and granted priority review status by the
FDA in February 2013.

After the Company has completed all outstanding questions and information
requests by the FDA, this represents an important step forward towards
market introduction of Epi proColon(R) in the USA.

- End of Ad hoc -

About FDA's advisory committee meetings
The FDA uses 50 committees and panels to obtain independent expert advice
on scientific, technical, and policy questions raised by the FDA as they
consider regulatory decisions. The FDA is not bound by the committee's
recommendation, but it takes its advice into consideration when reviewing
certain submissions. The Molecular and Clinical Genetics Panel of the
Medical Devices Advisory Committee reviews and evaluates available data
concerning the safety and effectiveness of marketed and investigational in
vitro devices for use in clinical laboratory medicine including clinical
and molecular genetics and makes appropriate recommendations to FDA. For
more information also refer to:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDe
vices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/de

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.


27.11.2013 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

---------------------------------------------------------------------------
 
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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