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Epigenomics AG: U.S. Representatives Payne and Marchant Introduce Bi-Partisan Colorectal Cancer Detection Bill

DGAP-News: Epigenomics AG / Key word(s): Miscellaneous

15.03.2019 / 12:40
The issuer is solely responsible for the content of this announcement.


Press release

U.S. Representatives Payne and Marchant Introduce Bi-Partisan Colorectal Cancer Detection Bill

Legislation aims to provide coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests

Berlin (Germany) and San Diego, CA (U.S.A.), March 15, 2019 – Representatives Donald Payne, Jr (D-NJ) and Kenny Marchant (R-TX) today introduced the ”Donald Payne Sr. Colorectal Cancer Detection Act” (HR 1765) to the United States House of Representatives in Washington D.C. This House Bill aims to provide payment and coverage under the Medicare program for FDA-approved qualifying colorectal cancer (CRC) screening blood-based tests.

“Screening utilizing blood testing mitigates patient barriers associated with typical colorectal cancer screening methods. The House Bill addresses the last barrier for Medicare patients – payment,” said Greg Hamilton, Chief Executive Officer of Epigenomics AG. “The passing of this bill provides millions of unscreened Americans access to CRC screening and ultimately saves thousands of lives.”

 

About colorectal cancer (CRC)

Colorectal cancer remains a leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35% of eligible U.S. patients are not being screened regularly. The unscreened population disproportionately results in 43% of new CRC cases and about 76% of CRC deaths and the associated costs. Approximately $18 billion is spent annually on this preventable disease in the U.S. Thereof, over $13 billion is spent on cases from unscreened individuals.

By increasing screening and detecting more cancers early, the costs and deaths from this disease both can be addressed. The addition of the blood-based methods to the Medicare covered services would increase screening access in both urban and rural areas where populations are less likely to be screened.

The Payne/Marchant effort is a bipartisan effort to address appropriate use of health care resources.

 

About Epi proColon(R)

Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods.

For patients, the test only requires a simple blood sample draw as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

For more information on Epi proColon, visit www.epiprocolon.com.

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, 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) and HCCBloodTest, blood-based tests for lung and liver cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

 

Contact in the U.S.
David Bull
Director of Marketing Phone: 240.912.6430

David.Bull@Epigenomics.com

Contact Epigenomics AG
Frederic Hilke
IR.on AG
Phone +49 221 9140 970
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 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.


15.03.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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Epigenomics AG: Release according to Article 40, Section 1 of the WpHG [the German Securities Trading Act] with the objective of Europe-wide distribution

Epigenomics AG

06.03.2019 / 09:27
Dissemination of a Voting Rights Announcement transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.


Notification of Major Holdings

1. Details of issuer

Name: Epigenomics AG
Street: Geneststraße 5
Postal code: 10829
City: Berlin
Germany
Legal Entity Identifier (LEI): 549300X1C4U862NDLN97

2. Reason for notification

X Acquisition/disposal of shares with voting rights
  Acquisition/disposal of instruments
  Change of breakdown of voting rights
  Other reason:


3. Details of person subject to the notification obligation

Legal entity: Morgan Stanley
City of registered office, country: Wilmington, Delaware, United States of America (USA)


4. Names of shareholder(s)
holding directly 3% or more voting rights, if different from 3.

 

5. Date on which threshold was crossed or reached:

26 Feb 2019

6. Total positions

  % of voting rights attached to shares
(total of 7.a.)
% of voting rights through instruments
(total of 7.b.1 + 7.b.2)
Total of both in %
(7.a. + 7.b.)
Total number of voting rights pursuant to Sec. 41 WpHG
New 1.64 % 0.09 % 1.73 % 36021540
Previous notification 3.04 % 0.09 % 3.14 % /

7. Details on total positions
a. Voting rights attached to shares (Sec. 33, 34 WpHG)

ISIN Absolute In %
  Direct
(Sec. 33 WpHG)
Indirect
(Sec. 34 WpHG)
Direct
(Sec. 33 WpHG)
Indirect
(Sec. 34 WpHG)
DE000A11QW50 0 589204 0.00 % 1.64 %
Total 589204 1.64 %

b.1. Instruments according to Sec. 38 (1) no. 1 WpHG

Type of instrument Expiration or maturity date Exercise or conversion period Voting rights absolute Voting rights in %
Right of recall over securities lending agreements at any time at any time 33619 0.09 %
    Total 33619 0.09 %

b.2. Instruments according to Sec. 38 (1) no. 2 WpHG

Type of instrument Expiration or maturity date Exercise or conversion period Cash or physical settlement Voting rights absolute Voting rights in %
0 0.00 %
      Total 0 0.00 %

8. Information in relation to the person subject to the notification obligation

  Person subject to the notification obligation is not controlled nor does it control any other undertaking(s) that directly or indirectly hold(s) an interest in the (underlying) issuer (1.).
X Full chain of controlled undertakings starting with the ultimate controlling natural person or legal entity:

Name % of voting rights (if at least 3% or more) % of voting rights through instruments (if at least 5% or more) Total of both (if at least 5% or more)
Morgan Stanley % % %
Morgan Stanley Capital Management, LLC % % %
Morgan Stanley Domestic Holdings, Inc. % % %
Morgan Stanley & Co. LLC % % %

9. In case of proxy voting according to Sec. 34 para. 3 WpHG
(only in case of attribution of voting rights in accordance with Sec. 34 para. 1 sent. 1 No. 6 WpHG)

Date of general meeting:
Holding total positions after general meeting (6.) after annual general meeting:

Proportion of voting rights Proportion of instruments Total of both
% % %

10. Other explanatory remarks:

 

Date

04 March 2019


06.03.2019 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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Epigenomics AG terminates collaboration with Chinese licensing partner and announces anticipated revenue growth in 2019 outlook

Epigenomics AG / Key word(s): Strategic Company Decision/Forecast
Epigenomics AG terminates collaboration with Chinese licensing partner and announces anticipated revenue growth in 2019 outlook

06-March-2019 / 20:57 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.


Epigenomics AG terminates collaboration with Chinese licensing partner and announces anticipated revenue growth in 2019 outlook

Berlin, March 6, 2019 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) today has decided to terminate its collaboration with its Chinese partner BioChain for the licensing of the Septin9 marker and the exclusive distribution rights in China for Epi proColon, a blood test for colorectal cancer detection, with immediate effect. The company makes use of its contractual right to terminate the agreement when BioChain did not pay Epigenomics more than the contractually agreed minimum royalties over a period of three years. Epigenomics AG will evaluate all options for the distribution of Septin9 in China to maximize the full potential of the test in this key market.

Taking also into account the termination of the license agreement with Biochain, the Company has today determined its outlook for the financial year 2019. Epigenomics AG expects revenues to be in a range of EUR 3.0 to 6.0 million (compared to EUR 1.5 million for the financial year 2018 based on preliminary, unaudited numbers). This represents an estimated increase in revenues of between 100% and 300% which is expected to be essentially driven by the new reimbursement rate published by Medicare of $192 per Epi proColon test. Adjusted EBITDA (EBITDA before share-based payment expenses) is expected to be in the range of EUR -11.5 to -14.0 million (compared to EUR -11.4 million for the financial year 2018 based on preliminary, unaudited numbers). Given the termination of the license agreement with Biochain, future licensing revenue on the Chinese market is not included in the outlook for 2019.

Explanatory notes regarding the term “EBITDA before share-based payment expenses” can be found in section 7.3 (pages 131-132) of the prospectus published by the Company on October 8, 2018. The prospectus is available on the internet at: www.epigenomics.com/news-investors/capital-increase.

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

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.

 


06-March-2019 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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Epigenomics AG: Korrektur einer Veröffentlichung vom 31.10.2018 gemäß § 40 Abs. 1 WpHG mit dem Ziel der europaweiten Verbreitung

Epigenomics AG

27.02.2019 / 10:46
Veröffentlichung einer Stimmrechtsmitteilung übermittelt durch DGAP – ein Service der EQS Group AG.
Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich.


Stimmrechtsmitteilung

1. Angaben zum Emittenten

Name: Epigenomics AG
Straße, Hausnr.: Geneststraße 5
PLZ: 10829
Ort: Berlin
Deutschland
Legal Entity Identifier (LEI): 549300X1C4U862NDLN97

2. Grund der Mitteilung

X Erwerb bzw. Veräußerung von Aktien mit Stimmrechten
  Erwerb bzw. Veräußerung von Instrumenten
  Änderung der Gesamtzahl der Stimmrechte
  Sonstiger Grund:


3. Angaben zum Mitteilungspflichtigen

Natürliche Person (Vorname, Nachname): Ari Zweiman
Geburtsdatum: 15.04.1972


4. Namen der Aktionäre
mit 3% oder mehr Stimmrechten, wenn abweichend von 3.

683 Capital Partners, LP

5. Datum der Schwellenberührung:

24.10.2018

6. Gesamtstimmrechtsanteile

  Anteil Stimmrechte
(Summe 7.a.)
Anteil Instrumente
(Summe 7.b.1.+ 7.b.2.)
Summe Anteile
(Summe 7.a. + 7.b.)
Gesamtzahl der Stimmrechte nach § 41 WpHG
neu 3,75 % 0 % 3,75 % 36021540
letzte Mitteilung n/a % n/a % n/a % /

7. Einzelheiten zu den Stimmrechtsbeständen
a. Stimmrechte (§§ 33, 34 WpHG)

ISIN absolut in %
  direkt
(§ 33 WpHG)
zugerechnet
(§ 34 WpHG)
direkt
(§ 33 WpHG)
zugerechnet
(§ 34 WpHG)
DE000A11QW50 0 1350000 0 % 3,75 %
Summe 1350000 3,75 %

b.1. Instrumente i.S.d. § 38 Abs. 1 Nr. 1 WpHG

Art des Instruments Fälligkeit / Verfall Ausübungs­zeitraum / Laufzeit Stimmrechte absolut Stimmrechte in %
%
    Summe %

b.2. Instrumente i.S.d. § 38 Abs. 1 Nr. 2 WpHG

Art des Instruments Fälligkeit / Verfall Ausübungs­zeitraum / Laufzeit Barausgleich oder physische Abwicklung Stimmrechte absolut Stimmrechte in %
%
      Summe %

8. Informationen in Bezug auf den Mitteilungspflichtigen

  Mitteilungspflichtiger (3.) wird weder beherrscht noch beherrscht Mitteilungspflichtiger andere Unternehmen, die Stimmrechte des Emittenten (1.) halten oder denen Stimmrechte des Emittenten zugerechnet werden.
X Vollständige Kette der Tochterunternehmen, beginnend mit der obersten beherrschenden Person oder dem obersten beherrschenden Unternehmen:

Unternehmen Stimmrechte in %, wenn 3% oder höher Instrumente in %, wenn 5% oder höher Summe in %, wenn 5% oder höher
Ari Zweiman % % %
683 Capital GP, LLC % % %
683 Capital Partners, LP 3,75 % % %
 
Ari Zweiman % % %
683 Capital Management, LLC 3,75 % % %

9. Bei Vollmacht gemäß § 34 Abs. 3 WpHG
(nur möglich bei einer Zurechnung nach § 34 Abs. 1 Satz 1 Nr. 6 WpHG)

Datum der Hauptversammlung:
Gesamtstimmrechtsanteile (6.) nach der Hauptversammlung:

Anteil Stimmrechte Anteil Instrumente Summe Anteile
% % %

10. Sonstige Informationen:

 

Datum

26.02.2019


27.02.2019 Die DGAP Distributionsservices umfassen gesetzliche Meldepflichten, Corporate News/Finanznachrichten und Pressemitteilungen.
Medienarchiv unter http://www.dgap.de


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Epigenomics AG: Release according to Article 40, Section 1 of the WpHG [the German Securities Trading Act] with the objective of Europe-wide distribution

Epigenomics AG

18.02.2019 / 14:52
Dissemination of a Voting Rights Announcement transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.


Notification of Major Holdings

1. Details of issuer

Name: Epigenomics AG
Street: Geneststraße 5
Postal code: 10829
City: Berlin
Germany
Legal Entity Identifier (LEI): 549300X1C4U862NDLN97

2. Reason for notification

X Acquisition/disposal of shares with voting rights
  Acquisition/disposal of instruments
  Change of breakdown of voting rights
  Other reason:


3. Details of person subject to the notification obligation

Legal entity: Morgan Stanley
City of registered office, country: Wilmington, Delaware, United States of America (USA)


4. Names of shareholder(s)
holding directly 3% or more voting rights, if different from 3.

Morgan Stanley & Co. LLC

5. Date on which threshold was crossed or reached:

11 Feb 2019

6. Total positions

  % of voting rights attached to shares
(total of 7.a.)
% of voting rights through instruments
(total of 7.b.1 + 7.b.2)
Total of both in %
(7.a. + 7.b.)
Total number of voting rights pursuant to Sec. 41 WpHG
New 3.04 % 0.09 % 3.14 % 36021540
Previous notification 2.76 % 0.10 % 2.86 % /

7. Details on total positions
a. Voting rights attached to shares (Sec. 33, 34 WpHG)

ISIN Absolute In %
  Direct
(Sec. 33 WpHG)
Indirect
(Sec. 34 WpHG)
Direct
(Sec. 33 WpHG)
Indirect
(Sec. 34 WpHG)
DE000A11QW50 0 1095924 0.00 % 3.04 %
Total 1095924 3.04 %

b.1. Instruments according to Sec. 38 (1) no. 1 WpHG

Type of instrument Expiration or maturity date Exercise or conversion period Voting rights absolute Voting rights in %
Right of recall over securities lending agreements at any time at any time 33619 0.09 %
    Total 33619 0.09 %

b.2. Instruments according to Sec. 38 (1) no. 2 WpHG

Type of instrument Expiration or maturity date Exercise or conversion period Cash or physical settlement Voting rights absolute Voting rights in %
0 0.00 %
      Total 0 0.00 %

8. Information in relation to the person subject to the notification obligation

  Person subject to the notification obligation is not controlled nor does it control any other undertaking(s) that directly or indirectly hold(s) an interest in the (underlying) issuer (1.).
X Full chain of controlled undertakings starting with the ultimate controlling natural person or legal entity:

Name % of voting rights (if at least 3% or more) % of voting rights through instruments (if at least 5% or more) Total of both (if at least 5% or more)
Morgan Stanley % % %
Morgan Stanley Capital Management, LLC % % %
Morgan Stanley Domestic Holdings, Inc. % % %
Morgan Stanley & Co. LLC 3.04 % % %

9. In case of proxy voting according to Sec. 34 para. 3 WpHG
(only in case of attribution of voting rights in accordance with Sec. 34 para. 1 sent. 1 No. 6 WpHG)

Date of general meeting:
Holding total positions after general meeting (6.) after annual general meeting:

Proportion of voting rights Proportion of instruments Total of both
% % %

10. Other explanatory remarks:

 

Date

15 Feb 2019


18.02.2019 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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Epigenomics AG: Release according to Article 40, Section 1 of the WpHG [the German Securities Trading Act] with the objective of Europe-wide distribution

Epigenomics AG

05.02.2019 / 14:14
Dissemination of a Voting Rights Announcement transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.


Notification of Major Holdings

1. Details of issuer

Name: Epigenomics AG
Street: Geneststraße 5
Postal code: 10829
City: Berlin
Germany
Legal Entity Identifier (LEI): 549300X1C4U862NDLN97

2. Reason for notification

X Acquisition/disposal of shares with voting rights
  Acquisition/disposal of instruments
  Change of breakdown of voting rights
  Other reason:


3. Details of person subject to the notification obligation

Legal entity: Morgan Stanley
City of registered office, country: Wilmington, Delaware, United States of America (USA)


4. Names of shareholder(s)
holding directly 3% or more voting rights, if different from 3.

 

5. Date on which threshold was crossed or reached:

31 Jan 2019

6. Total positions

  % of voting rights attached to shares
(total of 7.a.)
% of voting rights through instruments
(total of 7.b.1 + 7.b.2)
Total of both in %
(7.a. + 7.b.)
Total number of voting rights pursuant to Sec. 41 WpHG
New 2.76 % 0.10 % 2.86 % 36021540
Previous notification 3.75 % 0.13 % 3.88 % /

7. Details on total positions
a. Voting rights attached to shares (Sec. 33, 34 WpHG)

ISIN Absolute In %
  Direct
(Sec. 33 WpHG)
Indirect
(Sec. 34 WpHG)
Direct
(Sec. 33 WpHG)
Indirect
(Sec. 34 WpHG)
DE000A11QW50 0 993747 0.00 % 2.76 %
Total 993747 2.76 %

b.1. Instruments according to Sec. 38 (1) no. 1 WpHG

Type of instrument Expiration or maturity date Exercise or conversion period Voting rights absolute Voting rights in %
Right of recall over securities lending agreements at any time at any time 35219 0.10 %
    Total 35219 0.10 %

b.2. Instruments according to Sec. 38 (1) no. 2 WpHG

Type of instrument Expiration or maturity date Exercise or conversion period Cash or physical settlement Voting rights absolute Voting rights in %
0 0.00 %
      Total 0 0.00 %

8. Information in relation to the person subject to the notification obligation

  Person subject to the notification obligation is not controlled nor does it control any other undertaking(s) that directly or indirectly hold(s) an interest in the (underlying) issuer (1.).
X Full chain of controlled undertakings starting with the ultimate controlling natural person or legal entity:

Name % of voting rights (if at least 3% or more) % of voting rights through instruments (if at least 5% or more) Total of both (if at least 5% or more)
Morgan Stanley % % %
Morgan Stanley Capital Management, LLC % % %
Morgan Stanley Domestic Holdings, Inc. % % %
Morgan Stanley & Co. LLC % % %

9. In case of proxy voting according to Sec. 34 para. 3 WpHG
(only in case of attribution of voting rights in accordance with Sec. 34 para. 1 sent. 1 No. 6 WpHG)

Date of general meeting:
Holding total positions after general meeting (6.) after annual general meeting:

Proportion of voting rights Proportion of instruments Total of both
% % %

10. Other explanatory remarks:

 

Date

04 Feb 2019


05.02.2019 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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