Archives

Publication of inside information pursuant to Article 17 MAR

Epigenomics AG: Raise of earnings guidance for the current fiscal year 2022 due to currency gains and lower study costs

Berlin, September 19, 2022 – The Executive Board of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) raises its earnings guidance for the current fiscal year 2022 due to currency gains and efficiencies in study initiation costs. The currency translation gains are due to good currency management in connection with the positive development of the U.S. dollar. The initial set-up costs for the prospective FDA pivotal study for Epi proColon “Next-Gen”, for which the first subject was recently enrolled, were lower than anticipated.

For the full year 2022, the Executive Board now expects adjusted EBITDA (before share-based payment expenses) to be within the range of EUR -10.5 million to EUR -11.5 million and cash consumption in the range of EUR -14.5 million to EUR -15.5 million. Previously, the Company expected EBITDA (before share-based payment expenses) and cash consumption to range from EUR -15.0 million to EUR -17.0 million. The revenue forecast remains unchanged between EUR 0.3 million to EUR 0.8 million.

Contact:

Company
Epigenomics AG, Geneststrasse 5, 10829 Berlin
Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, Email: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, Email: ir@epigenomics.com

Note on forward-looking statements

This publication expressly or implicitly contains forward-looking statements concerning Epigenomics AG and its business. These statements involve certain known and unknown risks, uncertainties and other factors that may cause Epigenomics AG’s actual results, financial condition and performance to be materially different from any future results, performance or achievements expressed or implied by such statements. Epigenomics makes this announcement as of the date of this release and does not intend to update any forward-looking statements contained herein as a result of new information or future events or otherwise.

Epigenomics Initiates prospective multi-center clinical trial for “Next-Generation” blood-based colorectal cancer test

• First subject has been enrolled in the Company’s CRC-DRAW trial
• Data to be used as basis for planned PMA submission to FDA

Berlin (Germany) and San Diego, CA (U.S.A.), September 19, 2022 – Epigenomics Inc, a wholly-owned subsidiary of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”), today announced it has enrolled its first subject in a new pivotal clinical trial supporting the Company’s “Next-Generation” blood-based diagnostic screening test for the detection of colorectal cancer (CRC).

The prospective, multi-center study titled CRC-DRAW (CRC–Detection Reliable Assessment With Blood) will enroll screening eligible participants 45 years of age and older who are at average risk for colorectal cancer.  Over the course of the trial, it is expected to enroll over 15,000 subjects to achieve the proposed statistical endpoints needed for the study.  Clinical outcomes generated from CRC-DRAW will be used to support the planned Pre-Market Approval (PMA) submission of the Company’s “Next-Generation” CRC screening test with the U.S. Food and Drug Administration (FDA).

“CRC is still the number two cause of cancer deaths in the U.S. because numerous patients remain unscreened due to barriers with access” said Greg Hamilton, CEO of Epigenomics.  “More than ever physicians need options that patients will embrace and we believe that a reliable blood-based test that is effective and affordable provides a meaningfully differentiated solution to this problem.  We have initiated our CRC-DRAW trial because we are confident the improved performance of our “Next-Gen” test will give patients, physicians and providers an easy-to-use non-invasive option that will dramatically increase screening rates and ultimately save lives.”

“Epigenomics has been a long-standing pioneer in the liquid biopsy space with the first ever FDA approved cancer test from blood,” said Dr. Andrew A. Lukowiak, President and Chief Scientific Officer. “We have utilized this know-how and experience to augment our previous test with additional biomarkers to significantly improve the performance.  We look forward to presenting preliminary test performance data within the next couple of months.”
 

About Epigenomics

Epigenomics AG is a molecular diagnostics company focused on blood testing for the early detection of cancer. Based on its proprietary biomarker technology for the detection of methylated DNA, Epigenomics develops and markets blood tests for various cancer indications with high unmet medical need. Epigenomics’ lead product is the blood test Epi proColon® for the early detection of colorectal cancer. Epi proColon is approved by the U.S. Food and Drug Administration (FDA) and is marketed in the United States and Europe as well as other selected countries.

For further information please visit www.epigenomics.com.

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

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 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.

Epigenomics AG: Capital reduction planned at a ratio of 4 : 1
 

Berlin, September 9, 2022 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) plans to propose to the extraordinary Shareholders’ Meeting, which is to be convened on October 21, 2022 and conducted as a virtual general meeting without physical presence of the Shareholders or their proxies, in addition to the notification of loss pursuant to Section 92 par. 1 AktG, the reduction of the share capital to a quarter of the share capital at the time of the Shareholders’ Meeting.

The capital reduction is to take place in two steps. First, the share capital shall be reduced by withdrawing up to three treasury shares acquired free of charge so that the share capital is a multiple of four. Secondly, the share capital of the Company shall be reduced to a quarter by means of an ordinary capital reduction in accordance with Section 222 et seq. AktG. The ordinary capital reduction shall be carried out by combining the shares of the Company in the ratio 4 : 1 and serves partly to cover losses and partly to allocate to the Company’s capital reserves.

The specific amount of the capital reduction depends on amount of share capital as of the date of the extraordinary Shareholders’ Meeting on 21 October 2022 which in turn depends on whether and to what extent the holders of the convertible bonds issued by the Company exercise their conversion rights in the conversion window at the beginning of October 2022. Based on the share capital as of today in the amount of EUR 16,357,482.00 the share capital would be reduced by EUR 2.00 to EUR 16,357,480.00 by withdrawing shares and then by EUR 12,268,110.00 to EUR 4,089,370.00 by combining shares.

The complete agenda, together with explanations and more detailed information on registration for the extraordinary General Shareholders’ Meeting, can be found in the invitation, which is expected to be published in the Federal Gazette on September 14, 2022 and will also be available at https://www.epigenomics.com/news-investors/general-shareholder-meeting/.

Contact:

Company

Epigenomics AG, Geneststrasse 5, 10829 Berlin

Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, Email: contact@epigenomics.com

Investor Relations

IR.on AG, Frederic Hilke, Tel +49 221 9140 970, Email: ir@epigenomics.com

Note on forward-looking statements

This publication expressly or implicitly contains forward-looking statements concerning Epigenomics AG and its business. These statements involve certain known and unknown risks, uncertainties and other factors that may cause Epigenomics AG’s actual results, financial condition and performance to be materially different from any future results, performance or achievements expressed or implied by such statements. Epigenomics makes this announcement as of the date of this release and does not intend to update any forward-looking statements contained herein as a result of new information or future events or otherwise.

Epigenomics AG: Notice of Loss pursuant to Sec. 92 par. 1 AktG

Berlin, August 15, 2022 – The Executive Board of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) notifies that according to its best judgment a cumulative loss of more than half of the nominal share capital of the Company has been incurred. This anticipated development is mainly attributable to budgeted losses from regular business operations.

Pursuant to Sec. 92 par. 1 German Stock Corporation Act (“Aktiengesetz”), a loss amounting to half of the nominal share capital triggers the statutory obligation to convene without undue delay a general meeting of shareholders which the Executive Board notifies of the loss. Accordingly, the Company will convene in due time an extraordinary general meeting of shareholders.

Contact:
Company

Epigenomics AG, Geneststrasse 5, 10829 Berlin
Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, Email: contact@epigenomics.com
 

Investor Relations

IR.on AG, Frederic Hilke, Tel +49 221 9140 970, Email: ir@epigenomics.com

Note on forward-looking statements

This publication expressly or implicitly contains forward-looking statements concerning Epigenomics AG and its business. These statements involve certain known and unknown risks, uncertainties and other factors that may cause Epigenomics AG’s actual results, financial condition and performance to be materially different from any future results, performance or achievements expressed or implied by such statements. Epigenomics makes this announcement as of the date of this release and does not intend to update any forward-looking statements contained herein as a result of new information or future events or otherwise.

Epigenomics AG Reports Financial Results for the First Six Months of 2022

Berlin (Germany) and San Diego, CA (U.S.A.), August 10, 2022 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the “Company”) today reported financial results (IFRS, unaudited) for the second quarter and first half of 2022.

Key figures

• Total revenue increased slightly from EUR 223 thousand to EUR 241 thousand in the first half of 2022 compared with the same period of the previous year.
• Research and development costs increased from EUR 1,545 thousand in the first six months of 2021 to EUR 3,140 thousand in reporting period. The increase is due to investment in the “Next-Gen” product and increased enrollment of the post approval study compared to the reduced Covid-19 impacted enrollment of 2021. 
• Sales, General and Administrative expenses increased from EUR 3,021 thousand to EUR 3,582 thousand.
• EBITDA (before share-based payment expenses) amounted to EUR -3,677 thousand in the reporting period, compared with EUR -3,165 thousand in the same period of the previous year.
• The net loss for the period was EUR -3,957 thousand (H1 2021: EUR -3,528 thousand); the loss per share decreased from EUR 0.41 to EUR 0.24 compared to the prior-year period.
• Cash consumption increased to EUR 6,283 thousand in the first half of 2022, compared with EUR 4,214 thousand in the same period of the previous year.
• As of June 30, 2022, the Company had cash and cash equivalents of EUR 18,043 thousand (December 31, 2021: EUR 23,049 thousand).
• Epigenomics AG assumes that given the planned financial development, a cumulative loss of more than half of the nominal share capital will occur in the near future. The Company will, upon occurrence of the loss, make a corresponding publication and call a shareholders meeting pursuant to Section 92 par. 1 German Stock Corporation Act (“Aktiengesetz”) to which the loss will be notified.

Operational developments

• Epigenomics’ Executive Board remains confident that Epi proColon “Next-Gen” will meet the Centers for Medicare and Medicaid Services’ (CMS) reimbursement criteria (74% sensitivity and 90% specificity) and therefore filled a pre-submission with FDA for the clinical trial this spring. Patient enrollment is on-track to begin this summer. 
• The Company is also continuing its efforts to achieve CMS reimbursement for the current Epi proColon test via legislation. Sponsorship of the bill has increased to a bipartisan representation of 68 members of Congress. However, evaluating the prospects for success remains difficult.
• In order to achieve the goal of FDA approval and reimbursement for “Next-Gen”, the Company will need to raise additional capital to complete the trial and supporting activities required for subsequent FDA approval. The Company is actively exploring all methods to attract the necessary capital to achieve its goals, including a potential listing on an alternative exchange.

Greg Hamilton, CEO of Epigenomics AG: ” We are on track to accomplish our “Next-Gen” goals for 2022, specifically, initiation on the clinical trial and presentation of preliminary data. In order to deliver and commercialize “Next-Gen” the Company must raise the necessary capital. We believe that with the release of the preliminary data and the initiation of the study, we will be able to realize the significant market opportunity with “Next-Gen”.”

Outlook 2022

Revenue

• The Company confirms its outlook for fiscal year 2022 and continues to expect revenue within the range of EUR 0.3 million to EUR 0.8 million.

EBITDA / cash consumption

• For EBITDA (before share-based payment expenses), Epigenomics forecasts a range of EUR
  -15.0 million to EUR -17.0 million for the current full year 2022. Based on the Company’s 2022 business plan, cash consumption is expected to be in line with the EBITDA forecast (before share-based compensation expenses).

Further information

The interim statement for the first six months 2022 (unaudited) can be found on Epigenomics’ website at: https://www.epigenomics.com/news-investors/financial-reports/.

Conference call for analysts and investors  

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed at the following link: https://webcast.meetyoo.de/reg/MIx6NZ8bpVV8

The dial-in numbers for the conference call are:

Dial-in number Germany: +49 30 232531508
Dial-in number UK: +44 20 3872 0888
Dial-in number U.S.A.: +1 862-701-3057

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

About Epigenomics

Epigenomics AG is a molecular diagnostics company focused on blood testing for the early detection of cancer. Based on its proprietary biomarker technology for the detection of methylated DNA, Epigenomics develops and markets blood tests for various cancer indications with high unmet medical need. Epigenomics’ lead product is the blood test Epi proColon® for the early detection of colorectal cancer. Epi proColon is approved by the U.S. Food and Drug Administration (FDA) and is marketed in the United States and Europe as well as other selected countries. HCCBloodTest, a blood test for the detection of liver cancer, have received the CE Mark for marketing in Europe.

For further information please visit www.epigenomics.com.

Contact:
Company
Epigenomics AG, Geneststrasse 5, 10829 Berlin
Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, Email: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, Email: ir@epigenomics.com

Note on forward-looking statements

This publication expressly or implicitly contains forward-looking statements concerning Epigenomics AG and its business. These statements involve certain known and unknown risks, uncertainties and other factors that may cause Epigenomics AG’s actual results, financial condition and performance to be materially different from any future results, performance or achievements expressed or implied by such statements. Epigenomics makes this announcement as of the date of this release and does not intend to update any forward-looking statements contained herein as a result of new information or future events or otherwise.